Decision Making in Chronic Pain and Alcohol Use Disorder

Virginia Polytechnic Institute and State University

Status: Suspended

Conditions: Chronic Pain; Alcohol Use Disorder

Treatments: Device: Sham Low-intensity Focused Ultrasound; Behavioral: Episodic Future Thinking; Behavioral: Control Episodic Thinking; Device: Low-intensity Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05901610

VT IRB# 23-561

Details and patient eligibility

About

The objective of this within-subject study is to test the effects of Episodic Future Thinking (EFT) and Low-intensity Focused Ultrasound (LIFU) interventions on the pain of subjects who have chronic pain and alcohol use disorder(s).

Full description

This study will have a within-subject design. Participants will complete a baseline session (S1) and three intervention sessions. Specifically, participants will complete one intervention session consisting of episodic future thinking (EFT) and low-intensity focused ultrasound (LIFU), a second intervention session consisting of EFT and a control condition for LIFU ("sham-LIFU"), and an intervention session consisting of a control condition for EFT, called control episodic thinking (CET) and LIFU. Measures of chronic pain, alcohol valuation, alcohol craving, and delay discounting will be collected before and after each intervention session. The EFT intervention has participants generate positive events and related cues through a researcher-administered interview-based questionnaire. Participants will be asked to think about and describe positive events that could occur at each of the 6 delays in the future (i.e., 1 week, 1 month, 3 months, 1 year, 5 years, and 25 years). During the LIFU condition, participants will have an ultrasound transducer placed on their head, where brief ultrasound pulses are delivered to the desired brain area. CET requires participants to think about and describe positive events that occurred at each of 6 delays in the past (e.g., last night, yesterday in the afternoon, yesterday in the evening, yesterday in the morning, yesterday in the night, and the night before). After generating these cues participants will be asked to read and consider their cues as they complete the measures again that were collected prior to the cue generation. The sham LIFU condition may be active with ultrasound blocking, or inactive so that it would not deliver stimulation. All participants will complete all three intervention sessions. The first day will be the consent, MRI, and CT scans required for the LIFU intervention. The remaining three intervention sessions will occur in a counterbalanced order. The first and second sessions will be separated by 2-3 weeks, and the remaining sessions will be separated by approximately 1 week.

Enrollment: 10 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 21 years old or older
2. Report chronic pain
3. Have sufficiently stable self-reported mental and physical health in order to complete the survey
4. Meet DSM-V clinical criteria for alcohol use disorder (i.e., four or more criteria)
5. Not have unmanaged medical or psychiatric conditions the survey

Exclusion criteria

1. Claustrophobia (scanning environment may be uncomfortable)
2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
3. Contraindications to CT: pregnancy
4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
5. History of neurologic disorder (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for >10 minutes
7. Failure to provide a Social Security Number or Tax ID number. This is required for tax purposes.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 3 patient groups

EFT and LIFU

Other group

Description:

Participants will generate positive future events they are looking forward to at several time points in the future (e.g., 2 weeks, 1 month, 3 months, 1 year, and 5 years). During the LIFU condition, participants will have an ultrasound transducer placed on their head, where brief ultrasound pulses are delivered to the desired brain area using the imaging collected during visit 1. A small amount of ultrasound gel will be placed on the face of the single-element focused ultrasound transducer. The transducer will then be fitted on the scalp over the desired brain area and held in place with a mechanical arm. Brief pulses (0.2 to 2 seconds; duty cycle 10 - 70%; pulse repetition frequency 100 - 1000 Hz) of low-intensity (\< 50 W/cm2 Isppa), sub-thermal ultrasound (0.3 - 0.5 MHz) will be delivered in order to determine the area of activation, as well as the patterns of brain activity generated.

Treatment:

Device: Low-intensity Focused Ultrasound

Behavioral: Episodic Future Thinking

EFT and Sham LIFU

Other group

Description:

Participants will generate positive recent past events that have happened to them at several time points in the previous day (e.g., 7pm-10pm, 4pm-7pm, 1pm-4pm, 10am-1pm, and 7am-10am). During Sham LIFU, the device will be set up identically as in real LIFU. However, the device will be turned off.

Treatment:

Behavioral: Episodic Future Thinking

Device: Sham Low-intensity Focused Ultrasound

CET ad LIFU

Other group

Description:

Participants will generate positive recent past events that have happened to them at several time points in the previous day (e.g., 7pm-10pm, 4pm-7pm, 1pm-4pm, 10am-1pm, and 7am-10am). During the LIFU condition, participants will have an ultrasound transducer placed on their head, where brief ultrasound pulses are delivered to the desired brain area using the imaging collected during visit 1.

Treatment:

Device: Low-intensity Focused Ultrasound

Behavioral: Control Episodic Thinking